The ePass Clinical Trial for the Treatment of Obese Subjects

Not Applicable

• Conditions: Obesity
• Interventions: Device: ePass

• Registration Number: NCT02954016
• Lead Sponsor: ValenTx, Inc.

Brief Summary

To evaluate the safety and efficacy of the endoscopically implanted ValenTx EndoPass™ System for treatment of adults with severe obesity.

The EndoPass System is indicated for weight loss in adults with a body mass index (BMI) ≥35 and ≤ 50 kg/m2 who have failed more conservative weight loss methods.

Detailed Description

* Single-arm, multi-center study conducted in up to 50 subjects at up to 5 sites.

* Subjects will be implanted with the EndoPass device for up to 36 months.

* Body weight, adverse events and device function will be monitored at monthly visits for the first year after implant and quarterly visits thereafter.

* Additional follow-up data will include vital signs, hip and waist circumference, blood lab tests, endoscopic and esophagram assessments of the condition of the implanted device, quality of life and eating behavior questionnaires.

* All subjects will be followed for 12 months after device removal.

* A single device renewal may take place as needed after the initial implant.

* Subject study participation may last up to four years, but is expected to vary with implant duration, which will be determined on a case-by-case basis.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-09-23
• Status Verified: 2016-11
• Study First Submitted QC: 2016-11-01
• Last Update Submitted: 2016-11-01
• Study First Posted: 2016-11-03
• Last Update Posted: 2016-11-03
• Primary Completion: 2021-03
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• 18-60 years of age.
• BMI ≥ 35 and ≤ 50 kg/m2
• Documented failure with non-surgical weight loss methods
• Self-reported maximum and minimum body weights during the past 12 months within 10% of current body weight

Key

Exclusion Criteria

• Pregnancy or intention of becoming pregnant.
• Past history of esophageal, gastric or bariatric surgery.
• Medical conditions contraindicating elective endoscopic or bariatric procedures.
• Insulin-dependent diabetes mellitus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ePass	ePass	Subjects implanted with the investigational ValenTx Endo Bypass System

Primary Outcome Measures

Name	Time	Method
The proportion of subjects affected by serious adverse device effects (SADEs) as defined by International Standards Organization (ISO) standard 14155:2011.	1 Year	The proportion of subjects affected by SADEs during the 12 months following their device implant

Secondary Outcome Measures

Name	Time	Method
12 Month Weight Loss in Kilograms	1 Year	Mean reduction in bodyweight in kilograms from the day of implant to the 12 month post-implant follow-up visit.

Trial Locations

Locations (2)

Swiss Hospital / Especialidades Bariatrices; 🇲🇽 Monterrey, NL, Mexico

Hospital Italiano de Mendoza / Clinica Quiriurgica; 🇦🇷 Mendoza, Argentina